The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the guidance that surrounds it, and what notified bodies expect to see.
With less than a year to the IVDR date of application, we know that many manufacturers—especially those that were previously able to self-certify their IVDs—are struggling to get their technical documentation in order. In fact, many have not even engaged a notified body at this point. If you find yourself in this position, watch this webinar to get ahead of the game and learn about the challenges you can expect to face along the way. The more you know about what’s coming, the better you can prepare.
This webinar is presented by three RQM+ team members with extensive expertise in IVDR planning and execution and maintaining compliance:
- Kristen Meany, MS, CQA, RAC (US, EU) - Senior Principal Specialist
- Felicia Hosey, RAC - Senior Principal Specialist
- Ashley (Ash) Clark, MS, RAC - Senior Specialist
You can expect to learn from their hands-on experience with compiling technical documentation, working with notified bodies, and much more.
IVDR Compliance Challenges
Although the experience is different for every manufacturer, we have noted some common challenges that many in the IVD industry are facing with the implementation of the new regulation. In this webinar, you can expect to learn more about:
With just five designated notified bodies for IVDR (compared to the 20 designated for MDR) and a significant number of applications to review, you can expect there to be some bottlenecks. It’s worth noting that all four of the IVDR notified bodies are also designated for MDR, so they already have limited capacity and long certification timelines that are only expected to get longer as more manufacturers start the process.
IVDR requires manufacturers to classify devices based on the intended use and inherent risks. The rule-based approach is different from the list-based approach used under IVDD, so many manufacturers will have to determine how their devices should be classified. This is an important step because it informs the rest of the approval process and the required post-market activities. If your notified body disagrees with your determination, you will have lost precious time.
Quality management systems
Many manufacturers don’t realize that even if they have EN ISO 13485:2016 certification, they will still need to make changes to their quality management systems. This is because IVDR compliance goes beyond this standard. Although ISO certification is a good starting place, you cannot assume that no other work will be required. This comes as a surprise to many manufacturers and can potentially delay the review process, especially because an on-site audit is required.
Economic operators are another new element under IVDR. The regulation outlines obligations for manufacturers, authorized representatives, importers, and distributors within the quality management system. This will require most manufacturers to update contracts to include new responsibilities for each party. Coordinating this effort early in the process will help ensure timely compliance.
For manufacturers that were previously able to self-certify their IVDs, post-market surveillance that is monitored by a notified body is relatively new territory. The first step is to ensure that your technical documentation includes alignment between the various elements required for post-market surveillance. Although this might seem like a simple task, many manufacturers find that the systems and departments required to provide input—clinical, regulatory, quality management, and risk management—are not integrated and therefore produce data that is inconsistent, redundant, or otherwise requires normalization.
Training your employees
IVDR compliance is new territory for many manufacturers, which means that key employees in all affected departments—from design teams to purchasing personnel—must learn about the regulation and how it impacts their roles. This can be challenging in companies where departments are siloed and systems don’t communicate with each other.
While you can’t avoid investing resources into IVDR compliance, it is important to balance this investment with risk. Prioritizing your portfolio to ensure that your leading products are submitted first is a key step in the process. It’s also important to find the balance between building an overly robust technical file to avoid findings and not spending enough time to meet the expectations of your notified body.
IVDR Compliance Solutions
Fortunately, RQM+ has the experience and expertise to help you navigate these challenges. This webinar provides meaningful insights from people who have been doing the work and tips you can use right away to keep your IVDR application on track. For example, you will learn what steps you can take to:
- Optimize the review process with your notified body
- Determine IVD classification
- Integrate systems
- Upgrade quality management systems
No matter where you are in the IVDR application process, you will benefit from the lessons that have already been learned. Sign up today to attend the webinar and ask your IVDR questions.